Page 1
User's Manual TREATMENT LAMP ONYX TL-01 Serial number …………………………….. Release 3.0 June 2022...
Page 2
Producent: INFIMED Ltd. Kabaty 1 Street 34-300 Żywiec Poland WWW.INFIMED.PL Tel/fax +48 33 861 40 96 SRN: PL-MF-000015633 NIP 553 251 29 67 REGON 243274947 According to the classification of medical devices according to Regulation of the European Parliament and of the Council (EU) 2017/745, the table is classified as Class I.
1.3. Technical parameters .............. Błąd! Nie zdefiniowano zakładki. 1.4. General requirements ........................6 1.5. Product description ..............Błąd! Nie zdefiniowano zakładki. 1.6. Description of the components of the ONYX TL-01 lamp construction ... Błąd! Nie zdefiniowano zakładki. TL-01 treatment lamp ......................... 9 2.
1. Safety The product has been designed and manufactured to ensure its safe use and operation. The prerequisite for the safe use of the lamp is to read, understand and follow the rules contained in this manual. 1.1 General safety considerations - Do not use, operate or service the lamp in a manner inconsistent with these operating instructions.
Page 5
- For washing elements made of plastic, do not use any agents whose components destroy their structure. - If the product will not be used for a long period of time, it should be stored in the following environmental conditions: - temperature: 25⁰C (77⁰F) ±...
1.3. Technical parameters TL-01 60/100klx TL-01 30klx Parameters of Infimed ONYX treatment lamps: 60 klx (100klx-120klx)* 30 klx Ec illumination intensity 10 – 100% 10 – 100% Light intensity control 4300K (4800K)* 4300K (4800K)* Color temperature Tc 260mm (240-340mm )*...
Page 7
As an additional option, it also allows adjustment of the size of the light field. The Infimed Onyx treatment lamp is available in a single or double ceiling-mounted sling, wall-mounted, and a mobile version...
Page 8
Ceiling sling versions (double and single):...
Page 9
A wall-mounted and mobile version of the treatment lamp:...
1.5. Description of the components of the ONYX TL-01 lamp construction TL-01 treatment lamp 1 - control panel 2 - canopy arm system 3 - canopy 4 - sterile holder Treatment lampTL-01 30klx...
2. Transport and commissioning 2.1. Transport The product can be transported by all generally available covered means of transport. During transport, the product must be protected from moisture and dust and immobilized. During transport and storage, the temperature should be in the range from -10 to +60 degrees C, and humidity 20- 60%.
Attach the ceiling plate system to the existing ceiling in accordance with the Building Preparation Manual for Infimed lamps d) Attach the lamp mounting arm system, depending on the version of the lamp design (installation according to the Installation Manual on the bracket provided by the manufacturer)
LED indications 3 signal failure and battery or power status. 3.2. Adjustment with an adjustment handle (optional extra) The size of the light field is adjusted by turning clockwise or counterclockwise with the sterilizable adjustment handle.
- To remove the sterilizable handle, press the latch button (2) and, keeping it in the pressed position, pull the handle downward. - To install the holder, slide the holder (1) onto the guide until the latch (2) catches. 3.3. Positioning ONDAL production arms The following are used for positioning the lamp canopy: a sterilizable adjustment handle and lamp positioning handles on the edges of the lamp canopy.
Page 15
direction. Spring arm Inner ring Place for ring Hinge Hinge cover Spring arm SPR arm joint components Swivel arm Direction to increase arm spring force for higher loads/times Spring arm Direction of reduction of spring force of spring for smaller Imbus key loads/times Adjustment of the spring arm...
Function screw Spring arm Place of the function screw 4. Battery charging If the lamp is equipped with a charger for charging the batteries contained in the lamp, it should be connected to a power supply network with power parameters identical to those specified on the nameplate.
Do not store the table with discharged batteries - if the product is not used for more than a week, turn off the mains switch, and after a longer period of non-use of the product, recharge the batteries - at least once every six months. 5.
8. Cleaning and disinfection For cleaning and disinfection, use cleaning agents that do not contain active oxygen or chlorine. After disinfection, rinse with distilled water to eliminate streaks. Use a dry soft sterile cloth for thorough drying. Before disinfection, it is essential to disconnect the power cord. Do not use a water jet to wash the product.
All repairs, inspections and maintenance work should be recorded in the Repair and Maintenance Service Card included in the product instructions (Annex 2). 10. Condition checks and inspections In order to ensure that the product remains in good technical condition during its period of use, the user is obliged to submit it to periodic technical inspections.
12. Liquidation of the product The user is obliged to disinfect the product when deciding to stop using it (a product that is not disinfected in accordance with current environmental legislation is hazardous waste). 13. Lamp labels TL-01 treatment lamp labeling: Safety Manual Equipotential bonding...
Page 22
Annex 1 Recommended for surface cleaning and disinfection of products and components made of aluminium and powder-coated steel and plastics STEEL AND PREPARATE MATERIAL DISTRIBUTOR/MANUFACTURER ALUMINUM Aesculap-Chifa Sp.z o.o. ELISEPTOL st. Tysiąclecia 14 64-300 Nowy Tomyśl phone: 061 4420100 fax: 061 4437505 Bochemie PL Sp.
Page 23
Appendix 2 Repair and maintenance record of the product Type of lamp........Serial number…......Data zakupu ....Date of Type of review Person carrying out Signature of person Observations noted during inspection Review no. inspection (annual, semi- the inspection or carrying out the or repair or repair...